Once Swissmedic grants approval, the decisive phase begins at the Federal Office of Public Health (FOPH). Specialty List (SL):

Only medications on this list are reimbursed by health insurance companies (basic insurance). The "mix" of APV and TQV:

Foreign Price Comparison (APV): The FOPH looks at prices in reference countries (including Germany, Austria, and France). Since Lytenava is already priced in Germany, this price serves as the basis.

Therapeutic Cross-Comparison (TQV): This examines the prices of competing products such as Lucentis or Eylea in Switzerland. Since Lytenava is usually positioned at a lower price than these premium products, inclusion in the SL is very likely.

Innovation Premium: If Mediconsult can demonstrate that the approved form (instead of off-label use) offers a significant clinical advantage, a small price premium may be granted.

Responsibility: Mediconsult is solely responsible for submitting the marketing authorization application and maintaining the authorization. Planned market launch: Outlook Therapeutics and Mediconsult are aiming for the market launch of Lytenava™ in Switzerland in 2027.

Process duration: As Swissmedic conducts an independent review process (separate from the EMA approval in the EU), the standard review process typically takes between 12 and 16 months. However, you will likely apply for fast-track approval based on the UK/Germany/Austria approval, which is generally reduced by 5 months. Milestone payments will certainly be agreed upon at the time of submission.

Fast-Track; - 5 months possibly; = Switzerland has the possibility of joining as early as Q4.

SOURCE:

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